Stop-or-Not
Trial question
What is the effect of a continuation strategy of RAS inhibitors in patients scheduled to undergo a major noncardiac surgery?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
35.0% female
65.0% male
N = 2222
2222 patients (771 female, 1451 male).
Inclusion criteria: patients who were being treated with a RAS inhibitors for at least 3 months and were scheduled to undergo a major noncardiac surgery.
Key exclusion criteria: emergency surgery; hyperkalemia; terminal illness; severe renal insufficiency; preoperative shock.
Interventions
N=1107 continuation of RAS inhibitors (continued use of RAS inhibitors until the day of surgery).
N=1115 discontinuation of RAS inhibitors (discontinued use of RAS inhibitors 48 hours before surgery).
Primary outcome
Rate of all-cause mortality and major postoperative complications within 28 days after surgery
22%
22%
22.0 %
16.5 %
11.0 %
5.5 %
0.0 %
Continuation of RAS
inhibitors
Discontinuation of RAS
inhibitors
No significant
difference ↔
No significant difference in the rate of all-cause mortality and major postoperative complications within 28 days after surgery (22% vs. 22%; RR 1.02, 95% CI 0.87 to 1.19).
Secondary outcomes
Significant increase in episodes of hypotension during surgery (54% vs. 41%; RR 1.31, 95% CI 1.19 to 1.44).
No significant difference in median SOFA score at 7 days (2 points vs. 3 points; MD -0.24, 95% CI -1.9 to 1.41).
No significant difference in median length of hospital stay (5 days vs. 6 days; MD -0.23, 95% CI -0.78 to 0.32).
Conclusion
In patients who were being treated with a RAS inhibitors for at least 3 months and were scheduled to undergo a major noncardiac surgery, continuation of RAS inhibitors were not superior to discontinuation of RAS inhibitors with respect to the rate of all-cause mortality and major postoperative complications within 28 days after surgery.
Reference
Matthieu Legrand, Jérémy Falcone, Bernard Cholley et al. Continuation vs Discontinuation of Renin-Angiotensin System Inhibitors Before Major Noncardiac Surgery: The Stop-or-Not Randomized Clinical Trial. JAMA. 2024 Aug 30:e2417123. Online ahead of print.
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